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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE VDD-2 LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
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MPRI CAPSURE VDD-2 LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE Back to Search Results
Model Number 5038-58
Medical Device Problem Codes High Capture Threshold (3266); Unstable Capture Threshold (3269)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 7741, lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right ventricular (rv) lead and left ventricular (lv) lead exhibited high and unstable thresholds.The rv and lv leads remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE VDD-2 LEAD
Common Device Name
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10711237
Report Number2649622-2020-20341
Device Sequence Number11689669
Product Code DXY
UDI-Device Identifier00643169325678
UDI-Public00643169325678
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date09/16/2018
Device Model Number5038-58
Device Catalogue Number5038-58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2020
Initial Report FDA Received Date10/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
W4TR01 CRT-P, 479888 LEADS
Patient Age85 YR
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